Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

Condition	Intervention	Phase
Attention Deficit Disorder with Hyperactivity	Drug: ''''d, I (threo)-methylphenidate, Methylphenidate Transdermal System	Phase III

Further Study Details: 

Primary Outcomes: Score on ADHD Rating Scale at 4 weeks
Secondary Outcomes: Parent rating scale; Parent Global Assessment; Medication Satisfaction Survey; ADHD Impact Module; Clinical Global Impressions Scale; Adverse events, lab tests, dermal evaluations, ECGs
Expected Total Enrollment:  175

Ages Eligible for Study:  6 Years   -   12 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subject must have a primary diagnosis of ADHD
• Subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: Ritalin LA(r), Concerta(r), or Metadate DC(r), not to exceed 54 mg per day
• Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin pregnancy test

Exclusion Criteria:

• A history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually
• A recent history of suspected substance abuse or dependence disorder
• Subject is taking Strattera
• Clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites

Please refer to this study by ClinicalTrials.gov identifier  NCT00151983

Lisa Pickard      512 334 4005 

Arizona
      Meadowbrook Research, Inc., Scottsdale,  Arizona,  United States; Recruiting
California
      Psychiatric Centers at San Diego, San Marcos,  California,  United States; Recruiting
Colorado
      Alpine Clinical Research Center, Boulder,  Colorado,  United States; Recruiting
Florida
      Miami Research Associates, Inc., Miami,  Florida,  United States; Recruiting
Illinois
      Capstone Clinical Research, Libertyville,  Illinois,  United States; Recruiting
Kentucky
      Pedia Research, LLC, Owensboro,  Kentucky,  United States; Recruiting
Michigan
      ProMed Pediatrics, Kalamazoo,  Michigan,  United States; Recruiting
New Jersey
      Children''''s Specialized Hospital, Toms River,  New Jersey,  United States; Recruiting
North Carolina
      North Carolina Neuropsychiatry PA, Chapel Hill,  North Carolina,  United States; Recruiting
Ohio
      Ohio State University, Columbus,  Ohio,  United States; Recruiting
Oklahoma
      IPS Research Company, Oklahoma City,  Oklahoma,  United States; Recruiting
Oregon
      Oregon Center for Clinical Investigations (OCCI, Inc.), Portland,  Oregon,  United States; Recruiting
Pennsylvania
      CNS Research Institute, Philadelphia,  Pennsylvania,  United States; Recruiting
      Western Psychiatric Institute & Clinic, Pittsburgh,  Pennsylvania,  United States; Recruiting
Texas
      ADHD Clinic of San Antonio, San Antonio,  Texas,  United States; Recruiting
      Claghorn-Lesem Research Clinic, Bellaire,  Texas,  United States; Recruiting
Virginia
      Monarch Medical Research, Norfolk,  Virginia,  United States; Recruiting
      NeuroScience, Inc., Herndon,  Virginia,  United States; Recruiting

Study ID Numbers:  SPD485-305
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00151983
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13